Improved Retrospective Drug Utilization Review for Potential Opioid Overutilizers — Results from the Pilot

1. CMS logo Improved Retrospective Drug Utilization Review for Potential Opioid Overutilizers — Results from the Pilot CMS 2012 Medicare Advantage & Prescription Drug Plan Fall Enrollment, Marketing, and Compliance Conference Moderator: Cynthia G. Tudor, Ph.D., Director Medicare Drug Benefit and C&D Data Group September 5, 2012 Image of spilled med capsules

2. Session Overview • Background • Improved Retrospective DUR Programming and Case Management • Morphine Equivalent Dose (MED) Analysis • Pilot Panel • Questions 2

3. Background • Epidemic: Responding to America’s Prescription Drug Abuse Crisis, April 20111 • Opioid overdose is now the second leading cause of unintentional death in the United States, second only to motor vehicle crashes2 • People who abuse opioids have direct health care costs more than eight times those of nonabusers3 • GAO Report, Sept. 6, 2011,“Medicare Part D, Instances of Questionable Access to Prescription Drugs”4 1http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan.pdf 2Volkow ND, McLellan TA. Curtailing Diversion and Abuse of Opioid Analgesics Without Jeopardizing Pain Treatment. JAMA 2011;305(13):1346-1347. 3Unintentional drug poisoning in the United States [July 2010]. National Center for Injury Prevention and Control. Centers for Disease Control and Prevention. http://www.cdc.gov/HomeandRecreationalSafety/pdf/poison-issue-brief.pdf. 4GAO-11-699. (Washington, D.C.: Sept. 6, 2011). 3

4. Improved Retrospective DUR Programming & Case Management • For 2013, “Level Three” controls to apply to opioids (P&T Committee involvement) • Part D sponsors should look for apparent duplicative opioid drug use over sustained periods of time and/or across multiple opioid drug products in high doses • Focus on high dosage, sustained opioid use, and multiple providers 4

5. Improved Retrospective DUR Programming & Case Management • Clinical staff should communicate with prescribers and beneficiaries to ascertain medical necessity • Give prescribers information about the existence of multiple prescribers and the beneficiary’s total opioid utilization • Results of case management to confirm: 1) current level; 2) lower level; or 3) no opioids. No status quo if prescribers non-responsive and MEDIC referrals as appropriate • Provide 30-day advance written notice to beneficiary and opioid prescriber(s) of pending POS edits with the right to contest. No lock-in to specific prescribers or pharmacies 5

6. Morphine Equivalent Dose (MED) Analysis • MED is useful tool to assess and manage risks associated with use of opioids5,6 • CMS MED Analyses in Part D (2011 PDE) • Methodology • Identify exclusion criteria (cancer, hospice) • Develop MED conversion table for oral opioid analgesics • Calculate cumulative, daily MED for each beneficiary • Assess use of greater than 120 mg MED for at least 90 consecutive days • Add criteria for multiple prescribers and pharmacies 5Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92. 6Washington State Agency Medical Directors’ Group, Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An educational aid to improve care and safety with opioid therapy, 2010 Update. Available at www.agencymeddirectors.wa.gov. 6

7. Morphine Equivalent Dose (MED) Analysis • CMS MED Analyses in Part D (2011 PDE) • Results, excluding cancer and hospice care • 8.8 million (28%) opioid analgesic utilizers in Part D • 1.8 million (5.6%) exceeded 120 mg MED for at least one day • 225,000 (0.71%) exceeded 120 mg MED for at least 90 consecutive days • 22,222 (0.07%) also used more than 3 prescribers and more than 3 pharmacies during the 90-day period 7

8. Pilot Panel for “Level Three” • Participants: CVS/Caremark, Humana, UnitedHealthcare • Discussion • Targeting criteria/beneficiaries selected • Due Diligence • Outreach to prescribers and beneficiaries • Outcomes and follow-up • Lessons learned 8

9. QUESTIONS? Any additional questions about the Part D overutilization policy should be directed to PartDPolicy@cms.hhs.gov using the Subject Line “Overutilization.” 9